On August 6, 2003, Timothy “Woody” Witczak went out to his garage and hung himself from a rafter. The 37-year-old, who had no history of depression, had been prescribed the antidepressant Zoloft to treat the insomnia he had experienced since starting a new job.
Neither Woody nor his family were warned that one of Zoloft’s reported side-effects was suicidal behavior, despite the fact that for more than a decade, both Pfizer, the company that produces the drug, and the Food and Drug Administration had been aware of suicidal incidents linked to antidepressant use. In 2004, the FDA actually prevented one of its scientists from revealing the correlation to the House Energy and Commerce Subcommittee on Oversight.
Combined with the now infamous political intervention that stymied the approval process for the potentially over-the-counter morning-after pill Plan B, and the failure of the FDA to act in a timely manner in the Vioxx and Celebrex cases, it’s apparent that the agency is failing in its responsibility to regulate the products that account for 25 cents of every consumer dollar spent in the US.
Last week, the Union of Concerned Scientists released the results of an anonymous survey sent to 5,918 FDA scientists (of which, nearly 1,000 responded) that helps give a full picture of the dysfunction.
It paints an ugly picture.
The researchers’ answers portray a culture of discontent where scientists report not having enough resources to properly evaluate products, having scientific results ignored, being pressured by political appointees to approve drugs and—most criminal, considering the FDA’s mission—providing misleading information to the public.
The survey’s critics, led by FDA spokeswoman Susan Bro, argue that its questions were leading and unscientific. But what they cannot refute is the 69 pages of scientist-penned essays, which clearly describe some of the agency’s most disgusting practices: “They just take you off the product review if they don’t like your opinion,” was one common refrain. The scientists also reveal that “decisions are influenced by industry lobbying and political pressure,” and that a division Deputy Director would approve “a drug, regardless of the medical and statistical review, without ever looking at the data.”
In recent years, the FDA has been consistent in its denial of serious internal problems. In 2004, safety officer David Graham—who blew the whistle on Vioxx—testified in the Senate that the agency was unable to keep drugs that officers felt were unsafe off the market. Naturally, FDA officials refuted Graham’s testimony, labeling it “inaccurate” and “unscientific.”
Similarly, the Bush administration has been hiding discontent within the agency. In 2003, Janet Rehnquist, former inspector general for the Department of Health and Human Services and daughter of the late Chief Justice, released a report on the FDA’s drug review process containing glowing remarks of the agency’s success in streamlining drug approval as well as the happiness of its employees.
But when a Freedom of Information Act request revealed the full survey a year later, the truth came out: Two-thirds of the respondents thought the agency did not adequately monitor prescription drugs once they were on the market, 58% thought there was not enough time to review drugs and 18% said they were pressured to approve drugs they did not feel were safe. Most telling was the half of respondents who felt scientific dissent was not respected by the agency. (Rehnquist resigned in March of 2003 in the face of a stack of professional misconduct allegations.)
In light of the new survey, it’s hard not to find it incredible that the results of the Inspector General’s report did not spur improvement or serious action to rectify the situation at the FDA.
Congressmen on both sides of the aisle have been quick to point out that there needs to be a change in the agency’s culture and practices. But it was Congress itself that put pressure on the FDA to speed up its drug approval process, and increased the influence of industry on that process through the Prescription Drug User Fee Act. There have been few real attempts by Congress to improve safety and restore integrity to the agency, with the exception of Rep. Maurice Hinchey’s (D-NY) FDA Improvement Act, which aims to “cut the inappropriately close ties between the FDA and the drug industry and vastly improve the FDA’s drug safety operations.”
Unfortunately, in recent historical context, tying hopes to that bill seems futile.
Whenever there is a hearing on a health issue on Capitol Hill, patient advocates are asked to present horrifying personal stories of people who’ve been affected—a very powerful tool to tug at the heartstrings of politicians and staff. Only, it doesn’t seem to work when it comes to drug safety. For instance, Woody Witczak’s widow, Kim, has traveled to Washington 17 times since her husband died, and yet there has been no serious action on the part of Congress, the FDA leadership or the administration to make sure that scientific findings are not hidden from the public; neither have any steps been taken to ensure that FDA scientists can take action when they see a risk to public health.
Originally published July 25, 2006